Seven leading healthcare trade groups – representing hospitals, physicians, medical informatics professionals, IT executives and others – have called on Capitol Hill to take an active role in ensuring upcoming regulations on data exchange and information blocking are implemented in keeping with the goals of the 21st Century Cures Act.

WHY IT MATTERS
In a Sept. 23 letter to Sens. Lamar Alexander, R-Tennessee, and Patty Murray, D-Washington, the industry groups called on the leaders of the Senate HELP Committee to ensure the forthcoming regs from the Office of the National Coordinator for Health IT achieve goals of patient access while also promoting privacy and security and preventing clinician burnout.

The letter (which was sent at the onset of National Health IT Week) is signed by:

• American Health Information Management Association
• American Medical Association
• American Medical Informatics Association
• College of Healthcare Information Management Executives
• Federation of American Hospitals
• Medical Group Management Association
• Premier Inc.

"We write today to encourage the Committee's continued oversight to ensure that the 21st Century Cures Act is implemented in a manner that best meets the needs of patients and those who deliver their care," said the signatories.

While the groups emphasize that they're supportive of the rules' various proposals for electronic health record certification, use of APIs and new requirements around vendor and provider business practices, they also point to complex if not counterintuitive potential regs that could, they say, jeopardize Congress' data sharing goals.

Specifically, many of the rules could adversely affect patient privacy and security, impact patient safety and unduly add to clinician burden.

"It is imperative that policies be put in place to prevent inappropriate disclosures to third-parties and resultant harm to patients," said the groups, and not "unreasonably increase provider burden or hinder patient care."

Specifically, they made the following four requests:

• More rulemaking before the regulations are finalized, to help ensure "a sufficient level of industry review" and to get answers to outstanding questions.
• Enhanced privacy and security protections to better address the 21st Century Cures Act's data privacy rules. The trade groups also called on the HELP Committee to continue its oversight of privacy and security issues that fall outside of HIPAA.
• More realistic implementation timelines. "Providers must be given sufficient time to deploy and test these systems, which must take into account competing regulatory mandates."
• Revised and more lenient enforcement rules. The groups called on HHS to use discretion in its initial enforcement of the data blocking provisions of the regulation – prioritizing education and corrective action plans over monetary penalties.

THE LARGER TREND
Past Senate hearings have suggested that some on the HELP Committee may be sympathetic to the stakeholders' concerns. In March, Chairman Alexander wondered aloud: "Are we moving too fast?"

Alexander noted that, nearly a decade ago, he had "urged the Obama administration to slow down the meaningful use program which they did not do. And looking back the results would've been better if it had."

He also sought assurances that the regs would help "ensure patient privacy as patients gain more access and control over their personal health information." And he said he wanted to make sure the rules didn't leave the door open for "bad actors to game the system and continue to information block."

But during another hearing in May, National Coordinator for Health IT Dr. Donald Rucker told the committee that time was of the essence.

"To the extent that this is delayed or prevented, the American public is not in charge of their healthcare, they're paying more for their care, they're not getting as good care as they could get, and fundamentally they're not in control of their care," said Rucker.

ON THE RECORD
"The administration owes it to patients, physicians, Congress and our nation to listen and act on these concerns," said Dr. Jesse M. Ehrenfeld, chair of the American Medical Association's Board of Trustees, in a statement. "We still have a chance to get these policies right. It is possible to improve access to medical information while promoting privacy and transparency."

"We support the intent of the Cures Act to eradicate practices that unreasonably limit the access, exchange and use of electronic health information for authorized and permitted purposes that have frustrated care coordination and improvements in healthcare quality and efficiency," added AHIMA CEO Wylecia Wiggs Harris.

"However, in light of the lessons learned from the meaningful use program, we believe it is crucial that we get this right," she said. " We look forward to discussing the details of these recommendations with congressional staff and ONC."